Liver follow-up
17. Mrs F complains the Trust did not provide her husband with a six-monthly follow-up on his chronic liver disease and liver cirrhosis. She says her husband received a letter in May 2022 querying why he had not attended a follow-up appointment. Mrs F says her husband did not receive any notification of the appointment and she considers the delay in seeing a specialist led to a deterioration in his condition.
18. The Trust said it booked a follow-up for Mr F in early May 2022 which it says he did not attend as he had been unaware of the appointment. It said the next available appointment was mid-February 2023 which the Trust acknowledged was a very long wait and it apologised for this. The Trust said the rescheduled follow-up was because of the length of waiting lists at that time.
19. In November 2023, Mrs F and her family attended a meeting at the Trust, to speak with clinicians involved in her husband’s care. The Trust followed this with a letter to Mrs F in December. It said it would expect patients with liver cirrhosis to be followed up six monthly, with routine testing and an ultrasound scan.
20. NICE guidelines on cirrhosis say clinicians should refer patients who have or are at high risk of complications of cirrhosis to a specialist hepatology centre. The guidelines also say to offer an ultrasound every six months to look for signs of hepatocellular carcinoma (HCC – liver cancer) in people with cirrhosis.
21. Mr F had discussions with clinicians at the end of September 2021 where he discussed his alcohol related liver disease (ARLD) and his alcohol consumption.
22. ARLD is a condition where the liver is damaged by alcohol and there are three stages. The first is a build-up of fat in the liver and is characterised by scarring. The second stage is alcohol-related hepatitis where the liver becomes inflamed, and the scarring becomes more severe. The third stage is cirrhosis where the scarring significantly affects the liver’s ability to function and can lead to liver cancer or liver failure.
23. The Trust gave Mr F a gastroscope in November 2021. This is where a long, thin, tube containing a small camera is passed into the mouth then down the throat to look at the upper part of the digestive system. This confirmed Mr F had portal hypertensive gastropathy (a change in the stomach lining often caused by liver cirrhosis). An ultrasound scan showed he had features indicating chronic liver disease and an enlarged spleen.
24. A Trust consultant wrote to Mr F and his GP in December confirming Mr F had cirrhosis of the liver and that it was vital he remained completely abstinent from alcohol.
25. The consultant then wrote to Mr F and his GP in early May 2022 stating he had missed a clinic appointment. The letter said Mr F had been admitted to ED in the early hours of the morning with a seizure, queried whether it was alcohol related and confirmed another appointment would be sent to him in due course.
26. There is no evidence that the Trust told Mr F he had an appointment for May 2022.
27. A few days later, the Trust sent Mr F another letter which apologised for incorrectly stating he had been admitted to hospital and acknowledged he had been unaware of the scheduled appointment in May. The consultant said the clinic would arrange another appointment for him. The Trust says the next available appointment was mid-February 2023.
28. The appointment scheduled for Mr F in May 2022 would have been within the six-month timeframe from when he had his gastroscope and ultrasound scan in November 2021. However, this did not take place because the Trust did not tell him to attend. There was a nine-month delay between May 2022 and February 2023 when the Trust arranged Mr F’s new appointment. Our adviser said this was a particularly long wait in view of Mr F’s serious liver disease which required a six-monthly follow-up.
29. The Trust did not provide Mr F with a specialist appointment and an ultrasound of his liver between November 2021 and when he sadly died, 14 months later. This is not in line with NICE guidance and this is a failing.
Impact
30. Our adviser said it is difficult to determine how the failure to provide an appointment affected Mr F. They explained that the follow-up would have provided opportunities for Mr F to engage with alcohol services and we think it is likely that staff would have tried to persuade him to do this.
31. We find that the lack of a follow up deprived Mrs F and his family of the information they would have needed to make decisions about accessing services, changing lifestyle and being alert to deterioration in his liver condition.
32. We recognise that Mr F had previously been resistant to this type of support and we do not know if he would have engaged if the Trust had offered this. We also note he was told in December 2021 how important it was for him to abstain completely from alcohol.
33. Alcohol intake can be a risk factor for developing peptic ulcers. However, even if the Trust had arranged a follow up, it had offered a support and he had engaged with alcohol services, we do not know if this would have helped Mr F to reduce his alcohol intake. We also do not know if he had reduced his intake, if it would have prevented him developing an ulcer.
34. As such, we cannot say, on balance whether the delay in follow-up had a clinical impact on Mr F. However, this was a missed opportunity to encourage him to engage with alcohol services and to monitor his health.
35. Mr F’s family only found out ten months after his death that he should have had six-monthly follow-ups. This has caused them distress as they are left with the uncertainty of whether the follow-up could have made a difference to Mr F’s condition and outcome. We consider this to be an injustice in itself.
36. The Trust has apologised and acknowledged the follow-up appointment waiting time was very long. It said the rescheduled follow-up was in line with waiting lists at that time. We do not consider this goes far enough to put things right or explain how the Trust would prevent this situation occurring again.
37. We go on to explain our recommendations later in this report.
Omeprazole
38. Mrs F complains that the Trust stopped her husband's omeprazole when it admitted him to the Trust in November 2022. She said he had been taking this medication for a number of years to prevent him getting ulcers.
39. In the Trust’s complaint response, dated March 2023 it said it stopped Mr F’s omeprazole because he had hyponatremia (low sodium levels). It said this was not unreasonable, considering a gastroscopy two days earlier had not shown an ulcer.
40. BNF guidance on prescribing omeprazole explains that it belongs to a group of drugs known as a proton pump inhibitors (PPI) which reduce the production of stomach acid. It says it can be used to treat helicobacter pylori infection (H. pylori - a type of bacteria that can infect the lining of the stomach and the duodenum) in combination with other drugs.
41. It says omeprazole is used for the treatment of gastric (stomach) ulcers and duodenal (upper small intestine) ulcers. Gastric and duodenal ulcers are known as peptic ulcers and are caused by acidic stomach juices damaging the lining of the stomach. It also says omeprazole is a treatment for the prevention of a peptic ulcer returning (relapse) after it has healed.
42. The main causes of peptic ulcers are H. pylori infection and long term use of nonsteroidal anti-inflammatory drugs (NSAIDs). Smoking, alcohol consumption, and stress may also contribute to the development of peptic ulcers.
43. Mr F attended the Trust at the end of December 2018 after he had been vomiting blood. The Trust did a gastroscope and identified he had oesophagitis (inflammation of the food pipe) with acid reflux. It also showed he had erosive gastritis and erosive duodenitis. This is inflammation in an otherwise normal stomach and duodenum, causing some minor damage to the lining. These conditions can lead to peptic ulcers. The Trust prescribed him with omeprazole.
44. On the same date, the Trust also did a test for H. pylori which was negative. Our adviser explained that there can be false negative tests for H. pylori if a patient is on omeprazole or has gastric atrophy (where the stomach lining is thinned). However, Mr F was not on omeprazole before this point, and there is no evidence he had gastric atrophy at that time. Erosive gastritis is different to gastric atrophy. Our adviser said the likelihood is high that the H. pylori negative test was accurate.
45. There is no evidence of any further H. pylori tests after December 2018. Our adviser explained that H. pylori is most commonly contracted in childhood and so it is highly likely Mr F was still H. pylori negative after this.
46. Mr F attended the Trust in July and August 2019. At the beginning of August the Trust did a gastroscope and it showed he had a duodenal ulcer which was bleeding. The Trust put a metal clip on this to prevent it bleeding, gave him intravenous omeprazole and continued him with oral omeprazole on his discharge.
47. A further gastroscope in November 2019 showed that his duodenal ulcer had healed well. A Trust consultant told Mr F to continue taking omeprazole.
48. Our adviser said, as Mr F was likely to be H. pylori negative and was not a regular user of NSAIDs, the evidence does not show a clear cause of his ulcer.
49. Mr F attended ED in early November 2022 after he fell at home the previous day. He complained of recurrent falls, feeling dizzy, he had bruising on the right side of his chest and his face was swollen. Mr F also had dark tarry stools, ongoing fatigue (tiredness), worsening jaundice (yellowing of the skin) and a swollen abdomen.
50. ED clinicians diagnosed Mr F with an upper gastrointestinal haemorrhage (bleeding), and transferred him to the acute assessment unit. Medical staff treated Mr F with intravenous antibiotics, and for alcohol withdrawal.
51. The Trust conducted various investigations on Mr F including blood tests and a gastroscope. This showed mild gastritis (inflammation of the lining of the stomach) and no active bleeding.
52. During this admission Mr F’s sodium levels went as low as 120 mmol/L. NICE CKS says below 125 mmol/L is classed as severe hyponatraemia.
53. After reviewing Mr F’s gastroscopy results, clinicians stopped Mr F’s omeprazole. The discharge letter indicates that staff stopped this because of low sodium levels.
54. Mr F’s sodium levels rose to 136 mmol/L on the day of his discharge, 11 November. The Trust records show it considers a normal range to be 133 -146 mmol/L.
55. We asked the Trust to clarify why it stopped Mr F’s omeprazole. The Trust told us: ‘Mr F’s Gastroscopy was reported to be normal [in early] November 2022 hence there was no clinical indication to treat him with a proton pump inhibitor such as Omeprazole. Additionally his Sodium levels dropped dangerously low levels to 120 (normal 133- 146). As low sodium is well known side effect of Omeprazole or similar drugs, it was very appropriate to stop it. His urine sodium levels and osmolality supported this concern. Continuation of Omeprazole would in fact had impacted him adversely. Reassuringly his sodium levels had normalized before his discharge hence he was not restarted on it.’
56. Janicko et al shows that hyponatraemia happens in around 50% of patients who have liver cirrhosis (40% of outpatients and 57% of hospitalised patients).
57. NICE CKS on hyponatraemia says common causes include underlying medical conditions such as liver disease.
58. It says medications that may be contributing to the hyponatraemia should be stopped if appropriate and the sodium levels checked after two weeks. It lists the most common medications associated with hyponatraemia, which mainly include diuretics. These are drugs that help the body get rid of excess fluid and salt by increasing urine production.
59. It says omeprazole is a less common cause of hyponatraemia.
60. BNF omeprazole guidance says hyponatraemia is a ‘rare or very rare’ side effect.
61. Our adviser said low sodium levels do occur with omeprazole but this is usually seen in the first few days to weeks of starting the drug. They said the risk of hyponatraemia with long term omeprazole, as in Mr F’s case, was very low.
62. Issa et al support this view in their report. It says, there is an association between recently started omeprazole and hyponatremia. It says ‘Consequently, newly initiated PPIs should be considered a potential culprit in any patient suffering from hyponatremia. However, if the patient has had this treatment for a longer time, the PPI should be considered a less likely cause.’
63. Mr F attended ED on 28 December complaining of pain in his upper abdomen and staff recorded a suspected diagnosis of a peptic ulcer and other possible abdominal conditions. During this admission staff gave Mr F a single dose of omeprazole. However, on discharge staff did not prescribe or recommend the re-introduction of regular omeprazole.
64. Our adviser said that clinicians do not appear to have made the link between Mr F’s previous bleeding ulcer, the stopping of the omeprazole in November, and his risk of a recurrent ulcer.
65. On this admission, blood tests showed his sodium levels were near normal (132 mmol/L), and his liver function had improved. However, there is no evidence that staff gave any consideration to reintroducing omeprazole.
66. The Trust discharged Mr F with a diagnosis of diverticulitis and for a follow up with the gastroenterology department. Diverticulitis is an infection or inflammation of small pouches in the wall of the bowels.
67. Our adviser said the lack of a balanced decision over the failure to reintroduce omeprazole before staff discharged Mr F on 11 November and 29 December is a concern. They said it was not appropriate for the Trust to permanently stop Mr F’s omeprazole and said Mr F was at significant risk of relapse of an ulcer as this can occur at any time when a patient stops taking it. The Jae Hyun Seo et al review of H. pylori negative patients, shows that 36% had a relapse of a peptic ulcer within five years.
68. Trust doctors had previously prescribed him with omeprazole, on a long term basis for a potentially life-threatening problem, a bleeding peptic ulcer.
69. Our adviser said, as outlined in Janicko et al, hyponatraemia is very common in patients with liver disease. They said that Mr F’s liver disease was a more likely cause for his low sodium levels, rather than the omeprazole. They said this is a significantly more common reason for hyponatraemia, which is supported by NICE CKS, BNF and Issa et al.
70. Mr F had hyponatraemia when previously at the Trust, in March 2022, and clinicians did not stop his omeprazole. However, when he was at the Trust in November 2022 he had severe hyponatraemia. As such, our adviser said it was reasonable for doctors to temporarily stop his omeprazole. They said, however doctors should have restarted it in November or December.
71. Previous Trust clinicians made treatment plans for omeprazole in 2018 and 2019 to prevent and treat Mr F’s bleeding peptic ulcer. He had been taking omeprazole on a long-term basis when the Trust stopped it. In line with BNF, and supported by NICE CKS, the Trust missed opportunities to restart Mr F on omeprazole. These were in November when his sodium levels had improved and December 2022 when he complained of symptoms which indicated he could have a recurrence of a peptic ulcer. This is a failing.
Impact
72. Mrs F says her husband developed an ulcer which caused him worsening pain and led to his death because the Trust stopped his omeprazole.
73. We are very sorry to hear this caused her and her family such significant concern. We appreciate the loss of her husband has caused significant distress to Mrs F and her family.
74. We have carefully reviewed the evidence to consider what would have happened if the Trust had restarted Mr F on omeprazole in November or December 2022.
75. Mr F had a peptic ulcer which bled in August 2019. At this time, he had been taking omeprazole since December 2018. As such, he developed the ulcer when he was taking omeprazole.
76. We acknowledge that Mr F had been taking omeprazole for over three years after this, without recurrence of a peptic ulcer. We can understand Mrs F’s concern that two months after the Trust stopped his omeprazole, he developed an ulcer which bled and led to his death.
77. As we outline in paragraph 67, The Jae Hyun Seo et al review showed 36% of patients had a relapse of a peptic ulcer within five years.
78. The Jae Hyun Seo et al review also showed that omeprazole was not as effective at preventing relapse of an ulcer in patients who were H. Pylori negative, as it is highly likely Mr F was. We appreciate this was a study of a specific group of patients. Our adviser said some H. pylori negative patients will benefit from omeprazole, some will not.
79. Our adviser said the omeprazole would have provided some protection to Mr F’s stomach and duodenum lining. However, they said they could not categorically say that reintroducing omeprazole would have prevented Mr F developing a further ulcer.
80. For these reasons, we cannot say, even on balance, that reintroducing omeprazole would have significantly reduced the chances of him developing an ulcer.
81. What we can say is that it may have, and this was a missed opportunity to provide Mr F the chance of a better outcome.
82. Not knowing what the outcome would have been if the Trust had restarted omeprazole is a significant injustice to Mrs F in itself. We acknowledge that this uncertainty is likely to cause her and her family further distress.
83. We go on to make recommendations later in this report.
Communication following MDT
84. Mrs F complains the Trust did not disclose the severity of Mr F's condition after an MDT meeting in October 2022 and gave no clarity on the state of his liver. She also complains the lack of communication between medical teams and her family had a detrimental effect on her husband's quality of life and the wellbeing of his family.
85. The Trust said, after the MDT meeting, Mr F was due to be followed up in the clinic at the end of January 2023. The Trust also said following Mr F’s admission in November 2022 he would have been reviewed within 12 weeks but, as he already had an appointment this was not brought forward.
86. GMC guidelines say doctors must give patients information they want or need in a way they can understand. They say this should include information about their condition and that patients should be involved in decisions about their care. They go on to say doctors must start from the presumptions that all adult patients have capacity to make their own decisions.
87. GMC guidelines also say family members should be treated with care and compassion. However, it says the duty of confidentiality means that the communication should be with the patient. It is then for the patient to decide who they involve in their care.
88. The Trust admitted Mr F for eleven days in October 2022 where it provided treatment for pancreatitis (inflammation of the pancreas) and alcohol withdrawal. After the Trust discharged Mr F, he attended ED with a head injury following a fall. The Trust gave him an ECG and CT scan before Mr F self-discharged.
89. In mid-October, clinicians at an MDT meeting discussed Mr F’s case. They reviewed Mr F’s scans which showed an abnormality of the pancreas and a lesion on his liver which had remained unchanged from 2017.
90. Medical staff considered Mr F had pancreatic parenchymal necrosis (also known as necrotising pancreatitis - severe pancreas inflammation which causes tissue death) and that it could not rule out other serious conditions. The MDT recommended Mr F should be seen for follow-up in the gastroenterology clinic at the end of January 2023.
91. Mr F attended the Same Day Emergency Care (SDEC) unit at the Trust where staff reviewed his blood tests. On the same day as the MDT, a doctor from the SDEC wrote to Mr F’s GP confirming the necrotising pancreatis diagnosis and the results of his blood tests which it said it had explained to him at the time. The SDEC said it was discharging Mr F to his GP’s care.
92. Our adviser said in their view, the Trust response after the MDT in October was acceptable as investigations had revealed cancer was not present and an out-patient appointment was requested for review and discussion.
93. Mr F discussed his alcohol related liver disease with clinicians in September and November 2021. Clinicians also confirmed in December 2021 he had cirrhosis of the liver which is the final stage of alcohol related liver disease. There were no further details of his liver condition discussed at the MDT other than confirmation of liver cirrhosis and issues with his pancreas which the Trust informed Mr F and his GP of.
94. The evidence supports that the Trust made Mr F aware of the severity of his condition. The MDT in October 2022 was specifically to investigate whether Mr F had cancer, and the Trust ruled this out. It had arranged a follow-up at the end of January and sadly Mr F had died before this.
95. We consider the Trust did communicate with Mr F, and other relevant medical professionals in relation to his liver condition. The evidence suggests Mr F had capacity to understand what the Trust told him in October 2022 and there is nothing to suggest he asked the Trust to involve his family in these discussions. We consider this was in line with GMC guidelines and we find no failings here.
End of life communication and visiting
96. Mrs F says, in January 2023 the Trust did not contact her when staff knew Mr F was not going to survive after he had emergency surgery, and did not let the family visit as soon as they knew this.
97. We are sorry to hear how distressing it was for the family to find Mr F in such a serious condition when they arrived to see him.
98. The Trust apologised Mrs F had been unable to visit her husband before 2pm on the day he died. It acknowledged that for patients like her husband who were seriously ill, visiting should be unrestricted. The Trust said Mr F had experienced a rapid decline in the afternoon, and it sincerely apologised that Mrs F did not get more time with her husband.
99. The Trust visiting policy says patients can receive up to two visitors between 2pm and 8pm daily. The Trust told us that visiting outside of these times could be considered under exceptional circumstances such as end of life or patients with additional needs. The Trust’s policy does not make this clear.
100. GMC guidance says doctors must be considerate to those close to the patient and be sensitive and responsive in giving them information and support.
101. In mid-January, Mr F came out of theatre in the early hours, following emergency surgery to treat severe upper gastrointestinal bleeding. He was transferred to the critical care unit (CCU) where the Trust categorised him as needing the highest level of critical care.
102. Mrs F told us that medical staff called her in the early hours advising her they had admitted her husband to CCU and that her family could visit during standard visiting hours between 2pm and 8pm. Mrs F said staff also told her that Mr F’s surgeon and consultant wanted to speak to her when she arrived.
103. Four hours later, Medical staff completed a treatment escalation plan and cardio pulmonary resuscitation (CPR) decision form. On this form, a doctor issued a do not attempt cardio-pulmonary resuscitation (DNACPR) decision on Mr F. It says CPR would not be successful due to massive gastrointestinal bleeding, liver failure/cirrhosis and multi organ failure. It also says that his next of kin was to be updated.
104. There is no evidence of any communication from medical staff to Mrs F after they completed this form and before she arrived to see her husband during routine visiting hours.
105. The notes indicate the plan was for staff to monitor Mr F’s liver and to review him throughout the day. The records say that if Mr F’s liver decompensates (is not able to function properly) there would be nothing further medical staff could do.
106. Medical staff spoke with Mrs F and her family when they arrived to visit, explained Mr F had almost died during surgery and that he remained very unwell. Medical staff said they were concerned if his liver was to get worse he was unlikely to survive.
107. Medical staff explained Mr F had multi-organ failure and that it would not be in his best interests to continue with treatment. Staff agreed his life support would be removed when his family were ready and withdrew this early in the evening. He sadly died in the late evening.
108. We consider that the Trust should have explained the full nature of Mr F’s critical condition to Mrs F much earlier and given unrestricted visiting access to her husband. This was an exceptional circumstance due to Mr F’s condition. Staff wrongly informed Mrs F she could only visit her husband during standard visiting hours (2pm to 8pm) when they had discretion to allow her to visit at any time.
109. A doctor completed the DNACPR form in the morning and Mrs F visited the hospital several hours later. If the Trust had correctly informed Mrs F of the visiting policy, she would likely have attended and had conversations with medical staff much earlier.
110. By not doing so, the Trust did not communicate with Mrs F with care and compassion in line with GMC guidance. The Trust did not act in line with its own usual visiting arrangements for critically ill patients. This is a failing.
Impact
111. Mrs F tells us she and her family were deeply upset to learn she could have visited her husband earlier. She said when they arrived at the hospital the doctor told her she should let her family know the outlook was very poor for her husband. Mrs F said they could have spent those hours before 2pm saying goodbye to her husband and letting their family know to make travel arrangements to see him. Mrs F says this has been taken away from them and this is time they will never get back.
112. We recognise Mrs F and her family did get to spend some time with Mr F. This was before clinicians advised her in the evening that it was not in Mr F’s best interests for treatment to continue. We also appreciate that Mr F did not regain consciousness after surgery and could not have communicated with his family.
113. However, the incorrect application of the Trust’s usual arrangements for critically ill patients deprived Mrs F and her family of the opportunity to prepare themselves sooner, to be more involved with his care and to spend more time with him.
114. This is an injustice as Mrs F and her family were deprived of up to ten hours more time with her husband to say their goodbyes. We understand this has caused her and her family distress and we are very sorry to hear she still finds this upsetting. We recognise this would have always been a very upsetting time for the family, but we consider the failing we have found here, made this worse.
115. The Trust has apologised to Mrs F and acknowledged visiting times to see her husband should have been unrestricted as he was seriously ill. It is our view that an apology does not go far enough to address this failing, put this right for Mrs F, or prevent it from happening again.
116. We go onto explain our recommendations below.